Bazedoxifene Post Approval Safety Study (PASS) in the European Union (EU)
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT01416194
Collaborator
(none)
10,497
93.2
Study Details
Study Description
Brief Summary
This observational cohort study is being conducted to further characterize selected adverse events of interest among a patient population with osteoporosis who are prescribed bazedoxifene, raloxifene, or a bisphosphonate in usual clinical care outside of a randomized clinical trial setting. The study will compare the rates of the selected clinical events among the three treatment groups.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
All women in the database meeting the inclusion criteria will be included in the study without any statistical sampling.
Study Design
Study Type:
Observational
Actual Enrollment
:
10497 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
COHORT STUDY OF VENOUS THROMBOEMBOLISM AND OTHER CLINICAL ENDPOINTS AMONG OSTEOPOROTIC WOMEN PRESCRIBED BAZEDOXIFENE, BISPHOSPHONATES OR RALOXIFENE IN EUROPE
Actual Study Start Date
:
Jul 25, 2011
Actual Primary Completion Date
:
Apr 30, 2019
Actual Study Completion Date
:
Apr 30, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Bazedoxifene
|
Drug: Bazedoxifene
Patients receiving Bazedoxifene in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.
|
| Primary Comparator
|
Drug: Bisphosphonate
Patients receiving Bisphosphonates in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.
|
| Secondary Comparator
|
Drug: Raloxifene
Patients receiving Raloxifene in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.
|
Outcome Measures
Primary Outcome Measures
- Cumulative Incidence of Venous Thromboembolism (VTE) [Up to a maximum of follow-up period of 92.1 months]
VTE is defined as deep vein thrombosis (DVT), pulmonary embolism (PE), retinal vein thrombosis, and sinus thrombosis. DVT: occurs when a blood clot forms in a vein located deep inside the body. PE: a blockage of an artery in the lungs by a substance that has moved from elsewhere in the body through the bloodstream (embolism). Sinus thrombosis: presence of a blood clot in the dural venous sinuses, which drain blood from the brain. Retinal vein thrombosis: blockage of the small veins that carry blood away from the retina. Cumulative incidence was calculated as total participants with VTE events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants.
Secondary Outcome Measures
- Cumulative Incidence of Ischemic Stroke [Up to a maximum of follow-up period of 92.1 months]
Ischemic stroke is caused by a blockage in an artery that supplies blood to the brain. Cumulative incidence was calculated as total participants with ischemic stroke events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants.
- Cumulative Incidence of Cardiac Disorders [Up to a maximum of follow-up period of 92.1 months]
Cardiac disorders included myocardial infarction, myocardial ischemia, and coronary occlusion. Cumulative incidence was calculated as total participants with cardiac disorders events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants.
- Cumulative Incidence of Atrial Fibrillation [Up to a maximum of follow-up period of 92.1 months]
Atrial fibrillation is an irregular heartbeat that increases the risk of stroke and heart disease. Cumulative incidence was calculated as total participants with atrial fibrillation events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants.
- Cumulative Incidence of Biliary Events [Up to a maximum of follow-up period of 92.1 months]
Biliary events included cholecystitis and cholelithiasis. Cumulative incidence was calculated as total participants with biliary events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants.
- Cumulative Incidence of Hypertriglyceridemia [Up to a maximum of follow-up period of 92.1 months]
Hypertriglyceridemia refers to high blood levels of triglycerides. Cumulative incidence was calculated as total participants with hypertriglyceridemia events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants.
- Cumulative Incidence of Clinical Fractures [Up to a maximum of follow-up period of 92.1 months]
A fracture is a break in a bone. Cumulative incidence was calculated as total participants with clinical fractures events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants.
- Cumulative Incidence of Renal Failure [Up to a maximum of follow-up period of 92.1 months]
Cumulative incidence was calculated as total participants with renal failure events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants.
- Cumulative Incidence of All Malignancies [Up to a maximum of follow-up period of 92.1 months]
All malignancies included and not limited only to thyroid, breast, renal, genital / urogenital, lung cancer, gastrointestinal tract and respiratory tract. Cumulative incidence was calculated as total participants with malignancies events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants.
- Cumulative Incidence of Different Types of Malignancies [Up to a maximum of follow-up period of 92.1 months]
In this outcome measure, cumulative incidence of different types of malignancies included breast, renal, thyroid, genital / urogenital, gastrointestinal tract, lung and respiratory tract were calculated. Cumulative incidence for each type of malignancy was calculated as total participant with the respective malignancy events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence for each type of malignancy was expressed as percentage of participants.
- Cumulative Incidence of Depression [Up to a maximum of follow-up period of 92.1 months]
Cumulative incidence was calculated as total participants with depression events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants.
- Cumulative Incidence of Selected Ocular Events [Up to a maximum of follow-up period of 92.1 months]
Selected ocular events included retinal vascular occlusions, disorders of the globe, iris, ciliary body, retina, eye adnexa and cornea. Cumulative incidence was calculated as total participants with selected ocular events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants.
- Cumulative Incidence of Thyroid Disorders- Goitre [Up to a maximum of follow-up period of 92.1 months]
Goitre is a swelling in the neck resulting from an enlarged thyroid gland. Cumulative incidence was calculated as total participants with thyroid disorders-goitre events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Female
-
At least one prescription for bazedoxifene, raloxifene, or any bisphosphonate during the study inclusion period (index prescription);
-
A recoded diagnosis code of osteoporosis on or within 60 days prior to the index prescription date;
-
Age >=45 at the date of the index prescription; and
-
At least 6-months of follow-up data in the electronic medical record system prior to the date of the index prescription
Exclusion Criteria:
- There is no exclusion criteria. All women in the database who meet the inclusion criteria will be studied.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT01416194
Other Study ID Numbers:
- B1781044
First Posted:
Aug 12, 2011
Last Update Posted:
May 18, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Pfizer
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | This is a retrospective, observational, non-interventional study. Data was collected from proprietary longitudinal patient databases (LPD). |
|---|---|
| Pre-assignment Detail | The index date for each participant was the date of first recorded prescription for bazedoxifene, raloxifene or bisphosphonate. Follow-up period was from index date to first incident of primary event or date of last contact, whichever occurred first. Follow-up was maximum up to approximately of 92.1 months. |
| Arm/Group Title | Bazedoxifene | Raloxifene | Bisphosphonate |
|---|---|---|---|
| Arm/Group Description | Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per summary of product characteristics (SmPC) and dose was adjusted by physicians solely according to medical and therapeutic necessity. | Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. |
| Period Title: Overall Study | |||
| STARTED | 1111 | 2720 | 6666 |
| COMPLETED | 1111 | 2720 | 6666 |
| NOT COMPLETED | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Bazedoxifene | Raloxifene | Bisphosphonate | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | Total of all reporting groups |
| Overall Participants | 1111 | 2720 | 6666 | 10497 |
| Age, Customized (Count of Participants) | ||||
| From 45-49 years |
51
4.6%
|
78
2.9%
|
88
1.3%
|
217
2.1%
|
| From 50-59 years |
479
43.1%
|
665
24.4%
|
915
13.7%
|
2059
19.6%
|
| From 60-69 years |
382
34.4%
|
1229
45.2%
|
1915
28.7%
|
3526
33.6%
|
| From greater than equal to (>=) 70 years |
199
17.9%
|
748
27.5%
|
3748
56.2%
|
4695
44.7%
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
1111
100%
|
2720
100%
|
6666
100%
|
10497
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race and Ethnicity Not Collected (Count of Participants) | ||||
| Count of Participants [Participants] |
0
0%
|
|||
Outcome Measures
| Title | Cumulative Incidence of Venous Thromboembolism (VTE) |
|---|---|
| Description | VTE is defined as deep vein thrombosis (DVT), pulmonary embolism (PE), retinal vein thrombosis, and sinus thrombosis. DVT: occurs when a blood clot forms in a vein located deep inside the body. PE: a blockage of an artery in the lungs by a substance that has moved from elsewhere in the body through the bloodstream (embolism). Sinus thrombosis: presence of a blood clot in the dural venous sinuses, which drain blood from the brain. Retinal vein thrombosis: blockage of the small veins that carry blood away from the retina. Cumulative incidence was calculated as total participants with VTE events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants. |
| Time Frame | Up to a maximum of follow-up period of 92.1 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. |
| Arm/Group Title | Bazedoxifene | Raloxifene | Bisphosphonate |
|---|---|---|---|
| Arm/Group Description | Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. |
| Measure Participants | 1111 | 2720 | 6666 |
| Number (95% Confidence Interval) [percentage of participants] |
1.5
0.1%
|
2.2
0.1%
|
4.6
0.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene, Bisphosphonate |
|---|---|---|
| Comments | The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.01 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.4 | |
| Confidence Interval |
(2-Sided) 95% 0.3 to 0.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene, Raloxifene |
|---|---|---|
| Comments | The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.91 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.0 | |
| Confidence Interval |
(2-Sided) 95% 0.4 to 2.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Cumulative Incidence of Ischemic Stroke |
|---|---|
| Description | Ischemic stroke is caused by a blockage in an artery that supplies blood to the brain. Cumulative incidence was calculated as total participants with ischemic stroke events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants. |
| Time Frame | Up to a maximum of follow-up period of 92.1 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. |
| Arm/Group Title | Bazedoxifene | Raloxifene | Bisphosphonate |
|---|---|---|---|
| Arm/Group Description | Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. |
| Measure Participants | 1111 | 2720 | 6666 |
| Number (95% Confidence Interval) [percentage of participants] |
2.2
0.2%
|
2.6
0.1%
|
6.7
0.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene, Bisphosphonate |
|---|---|---|
| Comments | The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.01 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.5 | |
| Confidence Interval |
(2-Sided) 95% 0.3 to 0.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene, Raloxifene |
|---|---|---|
| Comments | The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.76 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.1 | |
| Confidence Interval |
(2-Sided) 95% 0.5 to 2.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Cumulative Incidence of Cardiac Disorders |
|---|---|
| Description | Cardiac disorders included myocardial infarction, myocardial ischemia, and coronary occlusion. Cumulative incidence was calculated as total participants with cardiac disorders events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants. |
| Time Frame | Up to a maximum of follow-up period of 92.1 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. |
| Arm/Group Title | Bazedoxifene | Raloxifene | Bisphosphonate |
|---|---|---|---|
| Arm/Group Description | Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. |
| Measure Participants | 1111 | 2720 | 6666 |
| Number (95% Confidence Interval) [percentage of participants] |
2
0.2%
|
3
0.1%
|
6.6
0.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene, Bisphosphonate |
|---|---|---|
| Comments | The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.01 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.6 | |
| Confidence Interval |
(2-Sided) 95% 0.3 to 0.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene, Raloxifene |
|---|---|---|
| Comments | The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.37 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.7 | |
| Confidence Interval |
(2-Sided) 95% 0.4 to 1.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Cumulative Incidence of Atrial Fibrillation |
|---|---|
| Description | Atrial fibrillation is an irregular heartbeat that increases the risk of stroke and heart disease. Cumulative incidence was calculated as total participants with atrial fibrillation events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants. |
| Time Frame | Up to a maximum of follow-up period of 92.1 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. |
| Arm/Group Title | Bazedoxifene | Raloxifene | Bisphosphonate |
|---|---|---|---|
| Arm/Group Description | Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. |
| Measure Participants | 1111 | 2720 | 6666 |
| Number (95% Confidence Interval) [percentage of participants] |
2.8
0.3%
|
4.3
0.2%
|
6.5
0.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene, Bisphosphonate |
|---|---|---|
| Comments | The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.10 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.7 | |
| Confidence Interval |
(2-Sided) 95% 0.5 to 1.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene, Raloxifene |
|---|---|---|
| Comments | The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.19 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.7 | |
| Confidence Interval |
(2-Sided) 95% 0.4 to 1.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Cumulative Incidence of Biliary Events |
|---|---|
| Description | Biliary events included cholecystitis and cholelithiasis. Cumulative incidence was calculated as total participants with biliary events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants. |
| Time Frame | Up to a maximum of follow-up period of 92.1 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. |
| Arm/Group Title | Bazedoxifene | Raloxifene | Bisphosphonate |
|---|---|---|---|
| Arm/Group Description | Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. |
| Measure Participants | 1111 | 2720 | 6666 |
| Number (95% Confidence Interval) [percentage of participants] |
1.8
0.2%
|
2
0.1%
|
4
0.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene, Bisphosphonate |
|---|---|---|
| Comments | The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.01 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.4 | |
| Confidence Interval |
(2-Sided) 95% 0.3 to 0.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene, Raloxifene |
|---|---|---|
| Comments | The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.90 |
| Comments | ||
| Method | Regression, Linear | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.0 | |
| Confidence Interval |
(2-Sided) 95% 0.4 to 2.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Cumulative Incidence of Hypertriglyceridemia |
|---|---|
| Description | Hypertriglyceridemia refers to high blood levels of triglycerides. Cumulative incidence was calculated as total participants with hypertriglyceridemia events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants. |
| Time Frame | Up to a maximum of follow-up period of 92.1 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. |
| Arm/Group Title | Bazedoxifene | Raloxifene | Bisphosphonate |
|---|---|---|---|
| Arm/Group Description | Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. |
| Measure Participants | 1111 | 2720 | 6666 |
| Number (95% Confidence Interval) [percentage of participants] |
9.7
0.9%
|
10.6
0.4%
|
6
0.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene, Bisphosphonate |
|---|---|---|
| Comments | The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.01 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.9 | |
| Confidence Interval |
(2-Sided) 95% 1.4 to 2.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene, Raloxifene |
|---|---|---|
| Comments | The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.74 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.9 | |
| Confidence Interval |
(2-Sided) 95% 0.7 to 1.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Cumulative Incidence of Clinical Fractures |
|---|---|
| Description | A fracture is a break in a bone. Cumulative incidence was calculated as total participants with clinical fractures events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants. |
| Time Frame | Up to a maximum of follow-up period of 92.1 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. |
| Arm/Group Title | Bazedoxifene | Raloxifene | Bisphosphonate |
|---|---|---|---|
| Arm/Group Description | Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. |
| Measure Participants | 1111 | 2720 | 6666 |
| Number (95% Confidence Interval) [percentage of participants] |
4.4
0.4%
|
8.2
0.3%
|
12.8
0.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene, Bisphosphonate |
|---|---|---|
| Comments | The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.01 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.4 | |
| Confidence Interval |
(2-Sided) 95% 0.3 to 0.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene, Raloxifene |
|---|---|---|
| Comments | The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.01 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.6 | |
| Confidence Interval |
(2-Sided) 95% 0.4 to 0.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Cumulative Incidence of Renal Failure |
|---|---|
| Description | Cumulative incidence was calculated as total participants with renal failure events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants. |
| Time Frame | Up to a maximum of follow-up period of 92.1 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. |
| Arm/Group Title | Bazedoxifene | Raloxifene | Bisphosphonate |
|---|---|---|---|
| Arm/Group Description | Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. |
| Measure Participants | 1111 | 2720 | 6666 |
| Number (95% Confidence Interval) [percentage of participants] |
0.8
0.1%
|
2.3
0.1%
|
4.8
0.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene, Bisphosphonate |
|---|---|---|
| Comments | The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.01 |
| Comments | ||
| Method | Regression, Linear | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.3 | |
| Confidence Interval |
(2-Sided) 95% 0.1 to 0.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene, Raloxifene |
|---|---|---|
| Comments | The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.06 |
| Comments | ||
| Method | Regression, Linear | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.4 | |
| Confidence Interval |
(2-Sided) 95% 0.2 to 1.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Cumulative Incidence of All Malignancies |
|---|---|
| Description | All malignancies included and not limited only to thyroid, breast, renal, genital / urogenital, lung cancer, gastrointestinal tract and respiratory tract. Cumulative incidence was calculated as total participants with malignancies events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants. |
| Time Frame | Up to a maximum of follow-up period of 92.1 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. |
| Arm/Group Title | Bazedoxifene | Raloxifene | Bisphosphonate |
|---|---|---|---|
| Arm/Group Description | Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. |
| Measure Participants | 1111 | 2720 | 6666 |
| Number (95% Confidence Interval) [percentage of participants] |
3.2
0.3%
|
4.4
0.2%
|
6.6
0.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene, Bisphosphonate |
|---|---|---|
| Comments | The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.01 |
| Comments | ||
| Method | Regression, Linear | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.5 | |
| Confidence Interval |
(2-Sided) 95% 0.3 to 0.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene, Raloxifene |
|---|---|---|
| Comments | The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.38 |
| Comments | ||
| Method | Regression, Linear | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.8 | |
| Confidence Interval |
(2-Sided) 95% 0.5 to 1.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Cumulative Incidence of Different Types of Malignancies |
|---|---|
| Description | In this outcome measure, cumulative incidence of different types of malignancies included breast, renal, thyroid, genital / urogenital, gastrointestinal tract, lung and respiratory tract were calculated. Cumulative incidence for each type of malignancy was calculated as total participant with the respective malignancy events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence for each type of malignancy was expressed as percentage of participants. |
| Time Frame | Up to a maximum of follow-up period of 92.1 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. |
| Arm/Group Title | Bazedoxifene | Raloxifene | Bisphosphonate |
|---|---|---|---|
| Arm/Group Description | Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. |
| Measure Participants | 1111 | 2720 | 6666 |
| Malignancies - Thyroid |
0.1
0%
|
0.2
0%
|
|
| Malignancies - Breast |
0.4
0%
|
0.6
0%
|
1.4
0%
|
| Malignancies - Renal |
0.1
0%
|
0.1
0%
|
|
| Malignancies - Genital / Urogenital |
0.5
0%
|
0.4
0%
|
0.5
0%
|
| Malignancies - Lung |
0.3
0%
|
0.4
0%
|
0.3
0%
|
| Malignancies- Gastrointestinal |
1.1
0.1%
|
1.1
0%
|
1.5
0%
|
| Malignancies- Respiratory |
0.1
0%
|
0.1
0%
|
| Title | Cumulative Incidence of Depression |
|---|---|
| Description | Cumulative incidence was calculated as total participants with depression events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants. |
| Time Frame | Up to a maximum of follow-up period of 92.1 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. |
| Arm/Group Title | Bazedoxifene | Raloxifene | Bisphosphonate |
|---|---|---|---|
| Arm/Group Description | Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. |
| Measure Participants | 1111 | 2720 | 6666 |
| Number (95% Confidence Interval) [percentage of participants] |
10.1
0.9%
|
9.2
0.3%
|
8.6
0.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene, Bisphosphonate |
|---|---|---|
| Comments | The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.24 |
| Comments | ||
| Method | Regression, Linear | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.2 | |
| Confidence Interval |
(2-Sided) 95% 0.9 to 1.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene, Raloxifene |
|---|---|---|
| Comments | The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.59 |
| Comments | ||
| Method | Regression, Linear | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.1 | |
| Confidence Interval |
(2-Sided) 95% 0.8 to 1.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Cumulative Incidence of Selected Ocular Events |
|---|---|
| Description | Selected ocular events included retinal vascular occlusions, disorders of the globe, iris, ciliary body, retina, eye adnexa and cornea. Cumulative incidence was calculated as total participants with selected ocular events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants. |
| Time Frame | Up to a maximum of follow-up period of 92.1 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. |
| Arm/Group Title | Bazedoxifene | Raloxifene | Bisphosphonate |
|---|---|---|---|
| Arm/Group Description | Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. |
| Measure Participants | 1111 | 2720 | 6666 |
| Number (95% Confidence Interval) [percentage of participants] |
8
0.7%
|
12.5
0.5%
|
10.8
0.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene, Bisphosphonate |
|---|---|---|
| Comments | The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.03 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.8 | |
| Confidence Interval |
(2-Sided) 95% 0.6 to 1.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene, Raloxifene |
|---|---|---|
| Comments | The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.19 |
| Comments | ||
| Method | Regression, Linear | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.8 | |
| Confidence Interval |
(2-Sided) 95% 0.6 to 1.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Cumulative Incidence of Thyroid Disorders- Goitre |
|---|---|
| Description | Goitre is a swelling in the neck resulting from an enlarged thyroid gland. Cumulative incidence was calculated as total participants with thyroid disorders-goitre events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants. |
| Time Frame | Up to a maximum of follow-up period of 92.1 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. |
| Arm/Group Title | Bazedoxifene | Bisphosphonate | Raloxifene |
|---|---|---|---|
| Arm/Group Description | Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. |
| Measure Participants | 1111 | 2720 | 6666 |
| Number (95% Confidence Interval) [percentage of participants] |
1.6
0.1%
|
2.5
0.1%
|
3.8
0.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene, Raloxifene |
|---|---|---|
| Comments | The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.01 |
| Comments | ||
| Method | Regression, Linear | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.3 | |
| Confidence Interval |
(2-Sided) 95% 0.2 to 0.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene, Bisphosphonate |
|---|---|---|
| Comments | The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.24 |
| Comments | ||
| Method | Regression, Linear | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.6 | |
| Confidence Interval |
(2-Sided) 95% 0.3 to 1.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | Not applicable as safety data was not planned to be collected during the study | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Safety data was not planned to be collected during the study. | |||||
| Arm/Group Title | Bazedoxifene | Raloxifene | Bisphosphonate | |||
| Arm/Group Description | Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | |||
All Cause Mortality |
||||||
| Bazedoxifene | Raloxifene | Bisphosphonate | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | |||
Serious Adverse Events |
||||||
| Bazedoxifene | Raloxifene | Bisphosphonate | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Bazedoxifene | Raloxifene | Bisphosphonate | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT01416194
Other Study ID Numbers:
- B1781044
First Posted:
Aug 12, 2011
Last Update Posted:
May 18, 2020
Last Verified:
Apr 1, 2020